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Safety and Efficacy of Antiadhesive Barrier GUARDIX-FL for Women After Laparoscopic Cystectomy

NCT02097446 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-27

No results posted yet for this study

Summary

* Indication: Benign tumors of ovary(mature teratoma, mucinous cystadenoma, serous cystadenoma)
* Intervention: Device ( Test group : Guardix-FL, Control group : Interceed)
* Primary Outcome Measure : Anti-adhesion Rate
* Assessment : Operative Day(Visit 2), Post-Operative Day+7days(Vist 3), Post-Operative Day+4weeks(Visit4), Post-Operative Day+5weeks(Visit 5)

Conditions

  • Genital Diseases, Female

Interventions

DEVICE

Guardix-FL

DEVICE

Interceed

Sponsors & Collaborators

  • Genewel Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Joong Sub Choi, Ph.D · Hanyang University Seoul Hospital

  • Seong Hun Kim, Ph.D · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097446 on ClinicalTrials.gov